Needleless Access Connectors and Valve Elements Therefor

ABSTRACT

A collapsible valve for use in a needleless access connector to reduce the priming volume of the needleless access connector. A needleless access connector with a small priming volume. A method of connecting a first medical device to a second medical device with a needleless access connector with a small priming volume.

TECHNICAL FIELD

This disclosure relates to needleless access connectors and moreparticularly to positive displacement needleless access connectors thathave a small priming volume.

BACKGROUND OF THE INVENTION

Modern medical treatment often requires medical professionals tointroduce fluids into a patient or withdraw fluids from a patient. Forexample, a patient may need treatment that requires a medicalprofessional to withdraw urine or blood from the urethra or a vein,respectively. Conversely, the medical professional may need to introducedrugs or nutrients into the patient's vein (i.e., intravenously). Tocreate a path for the flow of fluid into or from the patient, one methodrequires that the medical practitioner use a catheter where one end ofthe catheter is inserted into the patient. The other end of the catheterconnects to an intravenous bag (IV bag), through an IV line. Needlelessaccess connectors employ valves that allow a medical practitioner toremove or add devices (e.g., IV bags) to the catheter without the use ofa needle. An example of a needleless access connector is shown in FIGS.1A and 1B.

FIG. 1A is a cut-away view of a current needleless access connector 100.Needleless access connector 100 includes female luer fitting 101, maleluer fitting 102, and valve 103. When in use, male luer fitting 102 isconnected to, e.g., a catheter or to a female luer, and female luerfitting 101 is connected to a fluid reservoir, e.g., an IV bag or maleluer. Female luer fitting 101 is connected to the fluid reservoir via asecond male luer fitting 106, which has a hollow member (as shown inFIG. 1B) and is inserted through the top of female luer fitting 101. Theinsertion of male luer 106 collapses valve 103 down into volume 104 tobreak the seal and create a fluid flow path. FIG. 1B shows collapsiblevalve 103 in the collapsed position after insertion of male luer 106into female luer 101. Male luer 106 delivers fluid, e.g., from an IVbag, which flows around valve 103 into channels in male luer fitting 102and into the catheter or female luer.

Inside valve 103 is a gap (or septum, not shown), that is filled withair. Needleless access connector 100 is a positive displacement device,so that when a new connection is made at female luer fitting 101, device100 pulls fluid in from the male side of the valve (i.e., the sideproximate male luer fitting 102). When a disconnection is made at femaleluer fitting 101, device 100 pushes fluid in from the female side (i.e.,the side proximate the top of female luer fitting 101). The advantage ofpositive displacement is that when a disconnection is made, device 100expels fluid out of the male luer fitting 102 and effectively flushesthe catheter. By contrast, some devices on the market today havenegative displacement, so that when a male luer (e.g., male luer 106) isdisconnected, such devices pull a small amount of liquid from the maleluer 102 side. When liquid is pulled from the male luer 102 side of acatheter that is attached to the vein of a patient, blood could bepulled into the catheter lumen and if this blood is left in the catheterlumen it may clot and cause health problems for the patient. Positivedisplacement connectors avoid this problem by pushing fluid out when amale luer (e.g., male luer 106) is disconnected from the needlelessaccess connector and its collapsible valve moves from its collapsedstate to its uncollapsed state. The purging of fluid, from positivedisplacement connectors, helps to prevent blood from entering the tip ofthe catheter, thereby preventing blood clotting/contamination and thus,bloodstream infections.

In operation, when the female end of needleless access connector 100 isaccessed by a male luer (FIG. 1B), valve 103 is sufficiently elastic sothat it can bend out of the way to allow flow and then return to itsoriginal shape after a disconnection is made at the female end. Thus,needleless access connector 100 re-seals itself and forms a flat surfacethat can be disinfected at the top surface 110 using an alcohol swab.

Needleless access connector 100 has a partially annular valve bodybecause it has weakness points on both sides by virtue of duckbills 105.Duckbills 105 encourage the collapse of collapsible valve 103.Furthermore, needleless access connector 100 includes uniform wallthickness in the valve body, even at and around duckbills 105.

Before needleless access connector 100 is used to connect a device to,for example a catheter, needleless access connector 100 will containsome air. This air is removed before using needleless access connector100 with a catheter because otherwise it may be pumped into the patientcausing harm to the patient. Usually, to remove this air, the medicalpractitioner inverts the needleless access connector and attaches asyringe containing saline to the needleless access connector. The salineis then pushed through the needleless access connector, therebyexpelling the air from the connector. (This process is known as priming,and the minimum volume of liquid required to remove all the air from theneedleless access connector is known as the priming volume.) Somemedical practitioners prefer needleless access connectors with smallerpriming volumes to reduce delay in medication delivery.

After a needleless access connector is primed, the medical practitionerusually connects the male end 102 to a catheter (not shown) The medicalpractitioner connects a male luer from the IV bag (not shown) to theneedleless access connector. For example, a medical practitioner wouldconnect the end of syringe 106 to female luer fitting 101, as shown inFIG. 1B.

The preferences of medical practitioners, discussed above regardingneedleless access connectors, are significant especially in view of thefact that some of these medical practitioners, such as nurses, have toperform connecting of needleless access connectors many times during thecourse of a day.

BRIEF SUMMARY OF THE INVENTION

The present disclosure is directed to positive displacement needlelessaccess connectors that have a small priming volume. One embodiment ofthe invention is a collapsible valve for use in a needleless accessconnector. The collapsible valve includes a first portion with at leastone smiley cut in a section of this first portion. The collapsible valvehas a length of 0.62 to 0.82 inches. Further, the collapsible valve isadapted to provide positive displacement. Another embodiment of theinvention is a positive displacement needleless access connector thatincludes a housing and a collapsible valve disposed in the housing. Thecollapsible valve has a length of 0.62 to 0.82 inches. An apparatusaccording to one embodiment of the invention is a positive displacementneedleless access connector that includes a housing and a collapsiblevalve disposed in the housing. The housing and the valve cooperate sothat a volume of liquid required to expel air from the needleless accessconnector is about 0.17 to 0.19 milliliters.

Another embodiment of the invention is a positive displacementneedleless access connector that includes a housing and a collapsiblevalve disposed in the housing. A method according to one embodiment ofthe invention is for connecting a first medical device to a secondmedical device with a needleless access connector. The method includesinserting a male luer of the needleless access connector into the femaleluer of the second medical device. The method further includes insertinga male luer section of the first medical device into a female luer ofthe needleless access connector. The needleless access connector is apositive displacement needleless access connector that includes ahousing and a collapsible valve disposed in the housing. The collapsiblevalve has a length of 0.62 to 0.82 inches.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention. Itshould be appreciated by those skilled in the art that the conceptionand specific embodiment disclosed may be readily utilized as a basis formodifying or designing other structures for carrying out the samepurposes of the present invention. It should also be realized by thoseskilled in the art that such equivalent constructions do not depart fromthe spirit and scope of the invention as set forth in the appendedclaims. The novel features which are believed to be characteristic ofthe invention, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thateach of the figures is provided for the purpose of illustration anddescription only and is not intended as a definition of the limits ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawings, in which:

FIGS. 1A and 1B are cut-away views of a prior art needleless accessconnector;

FIG. 2A shows three exemplary collapsible valves used in tests ofneedleless access connectors;

FIGS. 2B-2C are cut-away, top-down views of different exemplaryconfigurations of a valve according to embodiments of the invention;

FIGS. 3A and 3B illustrate different views of an exemplary needlelessaccess connector according to one embodiment of the invention;

FIGS. 4A and 4B show flow channels in the housing of an exemplaryneedleless access connector according to one embodiment of theinvention; and

FIGS. 5A and 5B illustrate different views of the housing of anexemplary needleless access connector according to one embodiment of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

To address the issues of reducing priming volume, differentconfigurations of valves for needleless access connectors are disclosed.Tests were performed to establish operability and priming volume foreach positive displacement needleless access connector. Priming volumeis the minimum volume of liquid used to purge air from the needlelessaccess connector. The tests were conducted on three needleless accessconnectors each containing different collapsible valves. Theconfigurations of the three different collapsible valves are shown inFIG. 2A. It was observed that the amount and size of the duckbills,which are known in the prior art as being an important part of somecollapsible valves, and the reduction in length of the collapsiblevalve, as compared to prior art valves, affects priming volume of aneedleless access connector.

In one test where the duckbills were completely removed from thecollapsible valve (valve 200) and the valve was reduced to 0.72 inchesfrom a typical length of a prior art valve of 0.92 inches, it wasobserved that the priming volume for this valve was lower than the twoother valves—valve 201, which had small duckbills and valve 202, whichhad large duckbills. It should be noted that reducing the compressiblevalve length from 0.92 inches to 0.72 inches allows for the reduction intotal device length from 1.32 inches to 1.12 inches. Some test resultsare shown in TABLE I below.

TABLE I Illustration in Priming volume FIG. 2A (milliliters) Cylindrical200 0.175 Valve Small Duck 201 0.187 Bill Valve Large Duck 202 0.204Bill Valve

The results of the tests indicate that the priming volumes of needlelessaccess connectors that employ the configuration of valve200—miniaturized collapsible valves with a significant portion of theoutside surface being annular—may have a priming volume of around 0.175milliliters and concomitantly allow good flow rates, though variousembodiments may have different priming volumes. For example, the primingvolume may range from 0.17 to 0.19 milliliters.

Different configurations of collapsible valve 200 may have an annularoutside surface. For example, collapsible valve 200 includes firstportion 200A, second portion 200B and third portion 200C. First portion200A does not have a significant annular outside surface because it hasa smiley cut 200D interrupting the annular characteristic. In contrast,second portion 200B and third portion 200C both have annular outsidesurfaces. FIG. 2B shows second portion 200B cut in a plane, x,perpendicular to plane y. The annular outside surface shown in FIG. 2Brelative to plane y is circular. FIG. 2C shows another possible annularoutside surface. It should be noted that the axial length of the annularoutside surface does not include portions of the outside surface withcollapse assistance structures such as smiley cuts and duckbills. Forinstance, collapsible valve 201 has less axial length of its annularsurface than does collapsible valve 200 by virtue of the duckbills onsecond portion 201B which interrupt the annular characteristic.Collapsible valve 202 has even less axial length of its annular surfaceby virtue of its duckbills that dominate second portion 202B.

FIG. 2A illustrates exemplary embodiments of the invention. Collapsiblevalves 200 to 202 are miniaturized valves that may be used in aneedleless access connector. Collapsible valves 200 to 202 have smileycuts, 200D to 202D in first portions 200A to 202A, respectively.Collapsible valves 200 to 202 have a height (axial length) of 0.72inches but may be within the range of 0.62 to 0.82 inches in variousembodiments. Collapsible valves 200 to 202 are adapted to providepositive displacement, in part, by virtue of voids 200E to 202E. Beforethe needleless access connectors, in which collapsible valves 200 to 202are installed, are put in use, voids 200E to 202E contain air.

FIG. 2A illustrates that, in various embodiments of the invention, theannular portion of the outside surface of the collapsible valve spansabout 30% to 66% of the total axial length of the collapsible valve.Collapsible valves 200 to 202 have a total axial length of 0.72 inches.The amount of axial length of the annular surface varies amongst valves200 to 202 by virtue of the amount and size of the collapse assistancestructures present in each of these valves. Each of these valves hassmiley cuts in first portions 200A to 202A that cause a portion of theaxial length of valves 200 to 202 not to have an annular outsidesurface. In other words, the axial length of first portions 200A to 202Adoes not have an annular outside surface. First portions 200A to 202Ahave an axial length of about 0.25 inches or about 34% of the totalaxial length of valves 200 to 202. Thus, at least 34% of the axiallengths of valves 200 to 202 do not have an annular outside surfacebecause of smiley cuts 200D to 202D.

Considering valve 200, second portion 200B and third portion 200C haveannular outside surfaces. These annular portions represent the other 66%of the axial length of valve 200 (apart from first portion 200A) thathas an annular outside surface. Specifically, second portion 200B has anaxial length of about 0.4 inches or about 56% of the total axial lengthof valve 200. Third portion 200C has an axial length of about 0.07inches or about 10% of the total axial length of valve 200.

Collapsible valves 201 and 202 have even less outside annular surfacethan collapsible valve 200 because of the duckbills in second portions201B and 202B. Collapsible valve 202 for example, with the largerduckbills, may have an annular outside surface that spans about 30% ofthe axial length of valve 202 (i.e., 20% provided from second portion202B and 10% provided by third portion 202C).

FIG. 3A is a cut-away view of exemplary needleless access connector 300according to one embodiment of the invention. Needleless accessconnector 300 includes housing 301. Housing 301 may be made of materialincluding polycarbonate, polystyrene and acrylonitrile butadienestyrene. Housing 301 comprises top threaded part 302. It should be notedthat the configuration of top threaded part 302, in some embodiments,meets ISO standard 594. Similarly, the configurations of male luer 303at the base of needleless access connector 300, in some embodiments,meets ISO standard 594. Collapsible valve 304 is disposed within housing301.

Collapsible valve 304 may be made of elastic material such as siliconerubber, which is deformable and biocompatible. Because collapsible valve304 is made of deformable material, it will collapse when sufficientforce is applied to it. Collapsible valve 304 includes first portion304A, which is disposed within top threaded part 302 when valve 304 isin its uncollapsed state as depicted in FIG. 3A. First portion 304A maybe substantially cylindrical in shape and may contain deviations fromthis cylindrical shape such as smiley cut 304B. Collapsible valve 304also includes second portion 304C which is disposed in cavity 305 ofhousing 301. Unlike the prior art as depicted in FIG. 1, second portion304C is devoid of duckbills or any other such deviations from itsgeneral shape, i.e., portion 304C's outside surface is annular. As such,in one embodiment, second portion 304C is cylindrical and has diameterd2 being greater than diameter d1 of first portion 304A. Collapsiblevalve 304 may also include third portion 304D. Third portion 304D mayhave diameter d3 that is larger than second portion 304C's diameter, d2.

Collapsible valve 304 controls fluid flow through needleless accessconnector 200 and thereby provides a way of connecting devices to acatheter. In its uncollapsed state, as shown in FIG. 3A, collapsiblevalve 304 seals top threaded part 302. A further seal is provided atshoulder 307 by collapsible valve 304. When male luer 303 is connectedto the catheter 308, in creating a seal at opening 306 and shoulder 307,collapsible valve 304 also seals catheter 308. To connect anotherdevice, such as an IV bag, to catheter 308, male luer 309 is inserted inopening 306 as shown in FIG. 3B. Collapsible valve 304 collapses as aresult of the force imparted by male luer 309 and thereby allows fluidto flow from male luer 309 through needleless access connector 300,around valve 304 and into catheter 308, as shown in FIG. 3B.

In some embodiments of the invention, housing 301 includes flow channels401 as shown in FIGS. 4A and 4B. When collapsible valve 304 is in acollapsed state, flow channels 401 assist the flow of fluid aroundcollapsible valve 304 and into the catheter. As indicated in FIG. 4A,flow channels 401 may be disposed in the upper portions of housing 401.FIGS. 4A and 4B show six flow channels 401 on the inside of housing 301,which promotes fluid flow. In some embodiments, the width of flowchannel 401 is half the width of flow channels in typical needlelessaccess connectors.

FIGS. 5A-5C show outside views of exemplary needleless access connectorsaccording to one embodiment of the invention. It should be noted thatthe specific values given above are for exemplary embodiments and otherembodiments may have somewhat different values. Other configurationswith different sizes and shapes are within the scope of embodiments. Infact, any of a variety of positive displacement devices (and/or valves)can be adapted according to the concepts illustrated in the examplesabove.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.Accordingly, the appended claims are intended to include within theirscope such processes, machines, manufacture, compositions of matter,means, methods, or steps.

1. A collapsible valve for use in a needleless access connector, thecollapsible valve comprising: a first portion with at least one smileycut in a section thereof; and a second cylindrical portion configured toprovide positive displacement in said needleless access connector whenactuated.
 2. The collapsible valve of claim 1, wherein the secondportion has an axial length of 0.62 to 0.82 inches.
 3. The collapsiblevalve of claim 1, wherein the collapsible valve comprises elasticmaterial.
 4. The collapsible valve of claim 1, wherein the collapsiblevalve has an annular outside surface that spans 30% to 66% of an axiallength of the collapsible valve.
 5. A needleless access connectorcomprising: a housing; and a collapsible valve disposed in the housing,the collapsible valve comprising: a first portion with at least onesmiley cut in a section thereof; and a second cylindrical portioncoupled to the first portion, wherein the collapsible valve isconfigured to provide positive displacement when actuated.
 6. Theneedleless access connector of claim 5, wherein the housing comprises: amale fitting at one end; and a female fitting at the other end.
 7. Theneedleless access connector of claim 6, wherein the male and femalefittings comprise luer fittings.
 8. The needleless access connector ofclaim 5, wherein the housing is made from material selected from thelist consisting of: polycarbonate, polystyrene and acrylonitrilebutadiene styrene.
 9. The needleless access connector of claim 5,wherein the housing comprises channels adapted to allow fluid to flowthrough them when the collapsible valve is collapsed.
 10. The needlelessaccess connector of claim 5, wherein the second portion of thecollapsible valve has an axial length of 0.62 to 0.82 inches.
 11. Theneedleless access connector of claim 5, wherein the collapsible valvecomprises elastic material.
 12. The needleless access connector of claim5, wherein the collapsible valve has an annular outside surface thatspans 30% to 66% of the axial length of the collapsible valve.
 13. Theneedleless access connector of claim 5, wherein the needleless accessconnector has a length of 1.02 to 1.13 inches. 14-23. (canceled)
 24. Amethod of connecting a first medical device to a second medical device,the method comprising the steps of: inserting a male luer of aneedleless access connector into a female luer of the second medicaldevice; and inserting a male luer of the first medical device into afemale luer of the needleless access connector, thereby actuating acollapsible valve disposed with a body of the needleless accessconnector, the collapsible valve comprising a first portion with atleast one smiley cut in a section thereof and a second cylindricalportion, wherein the collapsible valve provides positive displacementupon insertion of the male luer into the female luer of the needlelessaccess connector.
 25. The method of claim 24, wherein the first medicaldevice comprises an intravenous (IV) bag and the second medical devicecomprises a catheter.